Chengdu Shengnuo: peptide API maker blocked at the border
FDA added this Chengdu peptide maker to Import Alert 66-40 on 19 September. It holds US DMFs for lanreotide, ganirelix and linaclotide. No warning letter is public yet.
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Products at risk. Who's in.
DMF on fileAPI, supply not confirmed
| MOLECULE | FORM | SOLD IN THE US BY | LINK TO SITE | RISK | WHO'S IN | Action |
|---|---|---|---|---|---|---|
| Lanreotide acetate | API (peptide) | Not disclosed | DMF ON FILE | IMPORT ALERT | 8 API (5 US DMF) | See who's in |
| Ganirelix acetate | API (peptide) | Not disclosed | DMF ON FILE | IMPORT ALERT | 8 API (5 US DMF) | See who's in |
| Linaclotide | API (peptide) | Not disclosed | DMF ON FILE | IMPORT ALERT | 10 API (9 US DMF) | See who's in |
FDA often redacts product names in its letters. Rows marked "FDA label" come from openFDA drug labels that name this site. "Who's in" counts manufacturers of the same molecule in the API-FDF database; names and contacts are inside.
What FDA found
- FDA put Chengdu Shengnuo Biopharm on Import Alert 66-40 on 19 September 2026. The entry covers all drugs and drug products from the firm.
- 66-40 is the alert for firms that have not met drug GMPs. US ports can hold their shipments without a physical exam.
- FDA has not posted a warning letter yet, so the findings behind the alert are not public.
Timeline
How it got here
19 SEP 2026
All drugs from the firm placed on Import Alert 66-40
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Warning letter with the findings. For Hanxin it came four months after the alert